CN105662659B - A kind of lumbosacral spine is axial to merge inner fixing device and its application method - Google Patents

Abstract

The present invention relates to a kind of lumbosacral spines for row lumbar spine sacral position integration technology axially to merge inner fixing device and its application method.The present invention is by threaded hollow screw head, hollow reticular component, sealing mat and several fixing screws composition, threaded hollow screw head and hollow reticular component are directly connected to, hollow reticular component and the sealing mat of lower section are directly connected to, and generally constitute that one hollow, middle part is that netted engraved structure, upper opening, lower section are sealed the lumbosacral spine of pad sealing axially fusion inner fixing device.Several fixed nail channels are equipped in hollow reticular component and sealing mat, fixing glue is pierced along fixed nail channel upwards by the sealing mat bottom fixing glue passway of sealing mat bottom, screw conduits opening drills out around reticular component, it is further fixed in the cortex bone of intervertenral space soleplate, can play and be firmly fixed.The present invention can provide enough fusion areas and strong fixation for lumbosacral spine.

Description

Lumbo-sacral axial fusion internal fixation device and method of use thereof

technical field

The invention relates to a lumbosacral vertebral axial fusion internal fixation device used for spinal lumbosacral fusion technology and a use method thereof. The design can provide sufficient fusion area and strong fixation for the lumbosacral vertebrae.

Background technique

Lumbar fusion is currently an effective method for treating various diseases of the lumbar spine and lumbosacral spine. After a century of development, lumbar fusion has various methods. In 1911, Hibbs implanted autologous spinous process bone fragments between the lamina to achieve fusion, that is, posterolateral (intertransverse) lumbar fusion. In 1948, Develand and Bosworth improved the Hibbs fusion by extending the graft bed laterally to the lateral facet of the articular process and the base of the transverse process. Although the PLF surgical approach is simple, easy to expose, and has fewer complications; it does not conform to the biomechanical characteristics of the spine, and cannot restore the stability of the anterior and middle columns; bone bed, aggravating the injury of the multifidus muscle. Also, the procedure is less effective for patients with discogenic low back pain.

The other is anterior lumbar intervertebral fusion. Entering the intervertebral space from the front can more effectively expand and restore the height of the intervertebral space. At the same time, the anterior approach can more thoroughly remove the degenerated intervertebral disc without pulling the dural sac and nerve root, thereby avoiding damage to the nerve root and dural sac. It also protects the integrity of the lumbar posterior structures such as lamina and facet joints. However, the anterior access to Luigi damages the great vessels and sympathetic nerve plexus, leading to complications such as retrograde ejaculation and urination disorders; at the same time, there are complications such as fusion cage sinking, loosening and prolapse, and loss of intervertebral height. Due to the relatively large surgical trauma and many complications, this technique is rarely used clinically to treat lumbar disc herniation.

Posterior lumbar interbody fusion was first reported by Cloward in 1953. Spinal canal decompression and discectomy can be completed at the same time, and intervertebral fusion can be completed through the posterior spinal canal to stabilize the anterior and middle columns of the lumbar spine. The disadvantage is that it is limited to the level of the lower lumbar spine, which can cause serious complications such as nerve and dura mater injury, bone graft prolapse, postoperative scar formation and recompression of the dura mater and nerve roots, epidural fibrosis and most of the epidural risk of loss of blood supply.

In 1982, Harms et al. performed transforaminal lumbar interbody fusion, entering the lumbar intervertebral space through the unilateral foraminal approach, and completed a series of processes such as discectomy, bone grafting, and intervertebral cage implantation. This operation can provide the support of the anterior and middle columns on both sides of the lumbar spine, and with the addition of posterolateral bone grafting and strong internal fixation, fusion of the lumbar spine can also be achieved, avoiding the risk of ALIF retroperitoneal organ damage.

However, all of the above surgical methods are open surgery, with relatively large trauma and many complications.

The current surgical methods mainly include minimally invasive percutaneous facet screw internal fixation and simple intervertebral fusion device implantation, but the safety of these surgical methods still needs further clinical verification.

In 2004, American scholar Cragg et al. first reported Axial Lumbar Interbody Fusion (AxiaLIF). AxiaLIF placed screws upward through the presacral rectal space to complete L5/S1 (lumbar 5/sacral 1) single segment Segment or L4/L5 (lumbar 4/5), L5/S1 double-segment fusion. This operation adopts the percutaneous technique, only needs to make a small incision of 10-20mm at the paracoccygeal notch and can perform the operation, and the natural gap of the presacral rectal space is used as the working channel, and the tissue trauma is small. This technique does not require laparotomy, and can reduce damage to muscles and ligaments, and most importantly, it does not damage the fibrous ring and stability at the L5-S1 level. The presacral approach can be done not only for L5/S1 single-level fixed fusion, but also for 2-level fusion, including L4/5 and L5/S1.

In 2010, Pan Tao disclosed an axial fixation system for intervertebral bone grafting (publication number: CN101627923A; publication date: January 20, 2010, patent application number: CN200910041848). The system uses screws to fix from the middle, and at the same time adopts the method of setting holes (circular or oval) in the body. This axial fixation system can provide axial fixation to a certain extent, but due to the circular structure of the system, the resistance to axial rotation is poor after implantation; and the system adopts a screw-like form, which has less contact with the surrounding area, and the intervertebral fusion The area is small; in addition, the limiting screw is located in the middle of the system, and the end of the limiting screw is in the cancellous bone of the upper vertebral body, resulting in poor pull-out resistance.

Contents of the invention

In order to overcome the above shortcomings, the design provides a wide fusion area, strong pull-out resistance, and strong axial rotation resistance. At the same time, the lumbosacral axial fusion internal fixation device can be inserted percutaneously or endoscopically and minimally invasively.

We have designed this lumbosacral axial fusion internal fixation device, and the present invention is realized by adopting the following technical solutions:

1. The present invention consists of a threaded hollow screw head, a hollow mesh member, a sealing pad and several fixing screws. The threaded hollow screw head is directly connected to the hollow mesh member, and the hollow mesh member is directly connected to the sealing pad below. The upper part constitutes a hollow internal fixation device for axial fusion of the lumbosacral vertebrae, the middle part is a mesh hollow structure, the upper part is opened, and the lower part is sealed by a sealing pad. When inserting the lumbosacral axial fusion internal fixation device in the axial direction, the whole body consisting of the threaded hollow screw head, the hollow mesh member and the sealing pad should be drilled from the bottom of the sacrum 1 upwards, and drilled with other bone drill tools in advance. The channel is inserted. The fixation nail passes through the opening of the fixation nail channel at the bottom of the sealing pad upwards to the side of the device at a certain angle, drills along the fixation nail channel, drills out through the opening of the screw channel around the mesh member, and is further fixed on the endplate of the intervertebral space on the cortical bone.

2. There is a large hollow hole in the middle of the threaded hollow screw head, and a thread on the outer surface. There may be holes around the screw head or no holes around the screw head. The hollow large hole directly connects with the hollow mesh member below. The interior communicates until the bottom of the sealing pad. Autologous bone or artificial bone can be filled in the hollow macropore and the hollow mesh member, and at the same time, some osteoinductive proteins and bone marrow mesenchymal stem cells that promote fusion can also be added to increase the fusion rate. The hole around the screw head designed around the threaded hollow screw head can also increase the contact area between the internal autologous bone or artificial bone and the vertebral body, and increase the rate of bone fusion. The hollow mesh member is a hollow mesh structure with countless mesh openings , provide sufficient contact area for the autologous bone or artificial bone implanted inside the present invention and the surrounding intervertebral space and vertebral body, and provide fusion rate and fusion strength.

3. The hollow mesh member is connected with the sealing pad at the bottom, so that the lower part is in a closed state, preventing the autogenous bone or artificial bone implanted in the hollow mesh member from leaking downward, and the hollow mesh member is connected with the sealing pad at the bottom according to the lower part of the sacrum The anatomical angle of the slope is designed according to different angles.

4. There are several fixing nail channels in the hollow mesh member and the sealing pad. The threads inside the fixing nail channel match and coincide with the fixing nail threads on the fixing nail. Screw channel openings around the shaped member and the fixing nail channel openings at the bottom of the sealing pad. Fixing nails are drilled upward along the fixing nail channel through the opening of the fixing nail channel at the bottom of the sealing pad, drilled out from the opening of the screw channel around the mesh member, and then further fixed on the cortical bone of the intervertebral space endplate, which can play a firm role. fixed.

The number of fixing nail channels can be different according to the actual needs. According to the data of the fixing nail channels, the corresponding number of fixing nail channel openings at the bottom of the sealing pad are designed correspondingly, and the corresponding number of mesh holes are also designed on the hollow mesh member. Screw channel openings around the member.

If only one nail channel is designed, the nail channel opening at the bottom of the sealing pad and the screw channel opening around the mesh member are both one. At this time, the device installed on the lumbosacral region is fixed at 2 points (hollow mesh member and one Fixing nails), poor torsion resistance and pull-out resistance, but simple and convenient installation.

If two nail channels are designed, there are two nail channel openings at the bottom of the sealing pad and two screw channel openings around the mesh member. At this time, the device installed on the lumbosacral region is fixed at 3 points (hollow mesh member and 2 fixed by a set of nails), the torsion resistance and pull-out resistance are strong, and the installation is a little more troublesome than the design of a nail channel.

If 3 nail channels are designed, there are 3 nail channel openings at the bottom of the sealing pad and 3 screw channel openings around the mesh member. At this time, the device installed on the lumbosacral region is fixed at 4 points (hollow mesh member and 3 fixed with a set of nails), at this time, the anti-torsion force and anti-drawing force are further increased, and the installation trouble is increased.

If 4 fixation nail channels are designed, there are 4 fixation nail channel openings at the bottom of the sealing pad and 4 screw channel openings around the mesh member. At this time, the device installed on the lumbosacral region is fixed at 5 points (hollow mesh member and 4 fixed with a set of nails), although the anti-torsion force and anti-pullout force have been increased, the installation trouble has also increased.

Therefore, excessively increasing the nail channels has little practical significance and will increase the difficulty of the operation, so the design of 1-4 nail channels is more reasonable.

5. There is a screwdriver hole at the bottom of the sealing pad.

6. The present invention is made of biocompatible titanium alloy or PEEK material (Polyetheretherketone) or magnesium alloy or stainless steel material. If the whole body is made of X-ray-transparent PEEK material, it is necessary to design X-ray-impermeable marking pins at both ends, so that the position of the device can be judged by X-rays after the operation.

Description of drawings

Figure 1: Schematic diagram of the present invention installed on the lumbar 5 sacral 1 segment.

Figure 2: Schematic diagram of the appearance structure of the present invention.

Figure 3: Schematic diagram of the structure of the longitudinal section of the present invention.

Fig. 4: Schematic diagram of an angled design structure of the central network structure and sealing pad of the present invention.

Fig. 5: A structural schematic diagram of a design of four screw holes on the bottom surface of the sealing pad of the present invention.

Fig. 6: A structural schematic diagram of another three-screw hole design on the bottom surface of the sealing pad of the present invention.

Fig. 7: A structural schematic diagram of another design of two screw holes on the bottom surface of the sealing pad of the present invention.

Fig. 8: A structural schematic diagram of another single screw hole design on the bottom surface of the sealing pad of the present invention.

Fig. 9: Schematic diagram of the structure of the fixing nail of the present invention.

Figure 10: Schematic diagram of the overall assembled structure of the present invention.

Fig. 11: Schematic diagram of the present invention installed in the segment from L4 to S1.

In the figure: 101. Hollow screw head with thread; 102. Hollow large hole; 103. Screw head thread; 104. Holes around the screw head; 201: Hollow mesh member; 202: Screw channel opening around the mesh member; 203: Fixing Nail channel; 301: sealing pad; 302: bottom of sealing pad; 303: fixing nail channel opening at the bottom of sealing pad; 304. Screwdriver hole at the bottom of sealing pad; 401: fixing nail; 402: fixing screw thread; 403: fixing nail tail; 404: screwdriver hole behind the fixation nail; 501: sacral 1 vertebral body; 502: lumbar 5 sacral 1 vertebral space; 503: lumbar 5th vertebral body; 504: lumbar 4/5 intervertebral space; 505: lumbar 4th vertebral body.

Detailed ways

Example 1

A patient needs lumbar 5 sacral 1 fusion because of disease in the lumbar 5 sacral 1 area. Make preoperative preparations. After anesthesia, the approach through the presacral space can be done under open surgery, under percutaneous conditions, or under endoscopic access. At the bottom of the 1st sacrum, a bone drill of a moderate size can be drilled. The hole directly reaches the lumbar 5 vertebral body. After other required decompression or intervertebral disc removal operations, the threaded hollow screw head (101) of the device faces upward and the sealing pad (301) faces downward, and the autogenous bone or The artificial bone is then installed in the pre-drilled hole, and then a screwdriver of a suitable size is selected and inserted into the screwdriver hole (304) at the bottom of the sealing pad, and the device is selected to be pushed forward, and the X-ray machine is used to locate the appropriate position. Select the fixing nail (401), drill through the fixing nail channel opening (303) at the bottom of the sealing pad (302) upward along the fixing nail channel (203), and drill out from the screw channel opening (202) around the mesh member, Then it is further fixed on the cortical bone of the intervertebral space endplate to play a role of firm fixation.

Example 2

A patient needs lumbar 4 to sacral 1 fusion because of disease in the lumbar 4 to sacral 1 area. Make preoperative preparations. After anesthesia, the approach through the presacral space can be done under open surgery, under percutaneous conditions, or under endoscopic access. At the bottom of the 1st sacrum, a bone drill of a moderate size can be drilled. After performing other required decompression or surgical procedures for removing the intervertebral disc, choose the device with a suitable length, turn the threaded hollow screw head (101) of the device upwards, and the sealing pad (301) Facing down, add autologous bone or artificial bone, then install it into the pre-drilled hole, then choose a screwdriver of appropriate size, put it into the screwdriver hole (304) at the bottom of the sealing pad, rotate and push the device, and pass it through the X-ray machine After the location is suitable. Select a suitable length of the fixing nail (401), drill through the fixing nail channel opening (303) at the bottom of the sealing pad (302) upwards along the fixing nail channel (203), and drill through the screw channel opening (202) around the mesh member Drilled out, and then further fixed on the cortical bone of the endplate to play a role of firm fixation.

Although the specific embodiments of the present invention have been described above, those skilled in the art should understand that these are only examples, and the present invention is not limited to 1 or 2 segments of spinal surgery. During multi-segment surgery, the present invention is applicable to different lengths required by different patients, and the present invention with different lengths and sizes is selected to be inserted.

The protection scope of the present invention is defined by the appended claims. Those skilled in the art can make various changes or modifications to these embodiments without departing from the principle and essence of the present invention, but these changes and modifications all fall within the protection scope of the present invention.

Claims (4)

1. a kind of axial fusion inner fixing device of lumbosacral spine, it is characterised in that: by threaded hollow screw head, hollow reticular component, Sealing mat and several fixing screws composition, threaded hollow screw head and hollow reticular component be directly connected to, hollow reticular component and The sealing mat of lower section is directly connected to, and generally constituting a hollow, middle part is netted engraved structure, upper opening, lower section quilt Axially fusion inner fixing device, hollow reticular component and sealing mat are interior logical equipped with several fixing glues for the lumbosacral spine of sealing mat sealing Road, the fixing glue screw thread on the screw thread and fixing glue of fixing glue channel interior is mating, identical, and the opening of fixed nail channel includes position The sealing mat bottom fixing glue passway of screw conduits opening and sealing mat bottom around the reticular component of hollow reticular component, Fixing glue is pierced along fixed nail channel upwards by the sealing mat bottom fixing glue passway of sealing mat bottom, from reticular component week It encloses screw conduits opening to drill out, is further fixed in the cortex bone of intervertenral space soleplate, can play and be firmly fixed, according to The number of fixed nail channel designs the sealing mat bottom fixing glue passway of corresponding number in sealing mat bottom accordingly, also exists It designs screw conduits opening around the reticular component of corresponding number on hollow reticular component, is equipped among threaded hollow screw head Empty macropore, outer surface are equipped with screw thread, and hollow macropore is directly communicated with the inside of the hollow reticular component of lower section, until the envelope of bottom Mouth pad.

2. lumbosacral spine according to claim 1 axially merges inner fixing device, it is characterised in that: hollow reticular component and bottom The sealing mat in portion connects, and makes lower section in closed state, hollow reticular component connects oblique below by rumpbone with the sealing mat of bottom The design of slope anatomical angulation size.

3. lumbosacral spine according to claim 1 axially merges inner fixing device, it is characterised in that: sealing mat bottom is equipped with one Play sub-aperture in a sealing mat bottom.

4. lumbosacral spine according to claim 1 axially merges inner fixing device, it is characterised in that: the device uses biofacies The titanium alloy or PEEK material (polyether-ether-ketone (Polyetheretherketone)) held either magnesium alloy or stainless steel Material is made, when device integrally uses PEEK material to be made, in the label needle of its both ends design X-ray opaque.